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Plastikon Healthcare Recalls
25 recalls on record · September 18, 2019 to September 14, 2022 · Drugs
Recalls by year
19
22
Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.
September 14, 2022DrugsFDA
Plastikon Healthcare LLC recalls CORRECTDOSE Children's COUGH & CHEST CONGESTION DM (Guaifenesin 100 mg / Dextromethorphan 5 mg per 5 mL) 2.04FL. OZ (60m
Hazard: CGMP Deviations: products manufactured under conditions which reflect manufacturing processes that were not adequately controlled.
September 14, 2022DrugsFDA
Plastikon Healthcare LLC recalls CORRECTDOSE Children's PAIN RELIEF & Fever Reducer, Cherry, (Acetaminophen 160 mg per 5 mL), 2.04 FL.OZ (60mL), package
Hazard: CGMP Deviations: products manufactured under conditions which reflect manufacturing processes that were not adequately controlled.
September 14, 2022DrugsFDA
Plastikon Healthcare LLC recalls CORRECTDOSE Children's ALLERGY RELIEF (Diphenhydramine HCl 12.5 mg per 5 mL), 2.04 FL. OZ (60 mL) packaged in 12- 5mL in
Hazard: CGMP Deviations: products manufactured under conditions which reflect manufacturing processes that were not adequately controlled.
September 14, 2022DrugsFDA
Plastikon Healthcare LLC recalls GUAIFENESIN AND DEXTROMETHORPHAN 200-20 mg/10 mL, 10 mL cup, packaged in 10 cups per tray, 10 trays per carton, For Inst
Hazard: CGMP Deviations: products manufactured under conditions which reflect manufacturing processes that were not adequately controlled.
September 14, 2022DrugsFDA
Plastikon Healthcare LLC recalls GUAIFENESIN AND DEXTROMETHORPHAN 100 mg-10 mg/5 mL, 5 mL cup, packaged in 10 cups per tray, 10 trays per carton, For Ins
Hazard: CGMP Deviations: products manufactured under conditions which reflect manufacturing processes that were not adequately controlled.
September 14, 2022DrugsFDA
Plastikon Healthcare LLC recalls Diphenhydramine HCl Oral Solution, 25 mg / 10 mL, 10 mL cup, packaged in 10 cups per tray, 10 trays per carton, For Inst
Hazard: CGMP Deviations: products manufactured under conditions which reflect manufacturing processes that were not adequately controlled.
September 14, 2022DrugsFDA
Plastikon Healthcare LLC recalls Diphenhydramine HCl Oral Solution 12.5 mg / 5 mL, 5 mL cup, packaged in 10 cups per tray, 10 trays per carton, For Insti
Hazard: CGMP Deviations: products manufactured under conditions which reflect manufacturing processes that were not adequately controlled.
September 14, 2022DrugsFDA
Plastikon Healthcare LLC recalls CALCIUM CARBONATE ORAL SUSPENSION, 1250 mg/5 mL, 5 mL cup, packaged in 10 cups per tray, 4 trays per carton, For Institu
Hazard: CGMP Deviations: products manufactured under conditions which reflect manufacturing processes that were not adequately controlled.
September 14, 2022DrugsFDA
Plastikon Healthcare LLC recalls Acetaminophen Oral Solution 650 mg / 20.3 mL, 20.3 mL cup, packaged in 10 cups per tray, 10 trays per carton, For Instit
Hazard: CGMP Deviations: products manufactured under conditions which reflect manufacturing processes that were not adequately controlled.
September 14, 2022DrugsFDA
Plastikon Healthcare LLC recalls Acetaminophen Oral Solution, 325 mg / 10.15 mL, 10.15 mL cup, packaged in 10 cups per tray, 10 trays per carton, For Ins
Hazard: CGMP Deviations: products manufactured under conditions which reflect manufacturing processes that were not adequately controlled.
September 14, 2022DrugsFDA
Plastikon Healthcare LLC recalls Acetaminophen Oral Solution 160 mg / 5 mL, 5 mL cup, packaged in 10 cups per tray, 10 trays per carton, For Institutiona
Hazard: CGMP Deviations: products manufactured under conditions which reflect manufacturing processes that were not adequately controlled.
September 14, 2022DrugsFDA
Plastikon Healthcare LLC recalls Magnesium Hydroxide 2400 mg, Aluminum Hydroxide 2400 mg, Simethicone 240 mg MAX, per 30 mL Oral Suspension, 30 mL cup, p
Hazard: CGMP Deviations: products manufactured under conditions which reflect manufacturing processes that were not adequately controlled.
September 14, 2022DrugsFDA
Plastikon Healthcare LLC recalls Magnesium Hydroxide 1200 mg, Aluminum Hydroxide 1200 mg, Simethicone 120 mg per 30 mL, 30 mL cup, packaged in 10 cups pe
Hazard: CGMP Deviations: products manufactured under conditions which reflect manufacturing processes that were not adequately controlled.
September 14, 2022DrugsFDA
Plastikon Healthcare LLC recalls MILK OF MAGNESIA USP, 2400 mg/10 mL, Magnesium Hydroxide, 30 mL cup, packaged in 10 cups per tray, 10 trays per carton,
Hazard: CGMP Deviations: products manufactured under conditions which reflect manufacturing processes that were not adequately controlled.
September 14, 2022DrugsFDA
Plastikon Healthcare LLC recalls MILK OF MAGNESIA USP, 2400 mg/30 mL, Magnesium Hydroxide, 30 mL cup, packaged in 10 cups per tray, 10 trays per carton,
Hazard: CGMP Deviations: products manufactured under conditions which reflect manufacturing processes that were not adequately controlled.
September 14, 2022DrugsFDA
Plastikon Healthcare LLC recalls Magnesium Hydroxide 2400 mg, Aluminum Hydroxide 2400 mg, Simethicone 240 mg MAX, per 30 mL Oral Suspension, 30 mL cup, p
Hazard: Microbial Contamination of Non-Sterile Products.
September 14, 2022DrugsFDA
Plastikon Healthcare LLC recalls Magnesium Hydroxide 1200 mg, Aluminum Hydroxide 1200 mg, Simethicone 120 mg per 30 mL, 30 mL cup, packaged in 10 cups pe
Hazard: Microbial Contamination of Non-Sterile Products.
September 14, 2022DrugsFDA
Plastikon Healthcare LLC recalls MILK OF MAGNESIA USP, 2400 mg/10 mL, Magnesium Hydroxide, 30 mL cup, packaged in 10 cups per tray, 10 trays per carton,
Hazard: Microbial Contamination of Non-Sterile Products.
September 14, 2022DrugsFDA
Plastikon Healthcare LLC recalls MILK OF MAGNESIA USP, 2400 mg/30 mL, Magnesium Hydroxide, 30 mL cup, packaged in 10 cups per tray, 10 trays per carton,
Hazard: Microbial Contamination of Non-Sterile Products
May 25, 2022DrugsFDA
Plastikon Healthcare LLC recalls Magnesium Hydroxide 1200mg, Aluminum Hydroxide 1200mg, Simethicone 120mg, 30 mL cup, packaged in 10 cups per tray, 10 tr
Hazard: CGMP Deviations: Failure to properly investigate failed microbial testing.
May 25, 2022DrugsFDA
Plastikon Healthcare LLC recalls MILK OF MAGNESIA USP, (Magnesium Hydroxide), 2400 mg/30 mL, 30 mL cup, packaged in 10 cups per tray, 10 trays per carton
Hazard: CGMP Deviations: Failure to properly investigate failed microbial testing.
May 25, 2022DrugsFDA
Plastikon Healthcare LLC recalls Acetaminophen Oral Solution, USP 650mg/ 20.3 mL cup, packaged in 10 cups per tray, 10 trays per carton, For Institutiona
Hazard: CGMP Deviations: Failure to properly investigate failed microbial testing.
May 25, 2022DrugsFDA
Plastikon Healthcare LLC recalls Magnesium Hydroxide 1200mg, Aluminum Hydroxide 1200mg, Simethicone 120mg, 30 mL cup, packaged in 10 cups per tray, 10 tr
Hazard: Microbial Contamination of Non-Sterile Products
May 25, 2022DrugsFDA
Plastikon Healthcare LLC recalls MILK OF MAGNESIA USP, (Magnesium Hydroxide), 2400 mg/30 mL, 30 mL cup, packaged in 10 cups per tray, 10 trays per carton
Hazard: Microbial Contamination of Non-Sterile Products
September 18, 2019DrugsFDA
Plastikon Healthcare LLC recalls Milk of Magnesia USP, 2400 mg/30 mL, Magnesium Hydroxide 2400 mg, 30 mL unit dose cups, For Institutional Use Only, pack
Hazard: Microbial Contamination of Non-Sterile Products: product failed bioburden testing for Total Aerobic Microbial Count.